SchizophreniaPhase 1NCT06105151
Study of the Safety, Tolerability, Pharmacokinetics and Food Effects of VV119 Capsules in Chinese Healthy Volunteers
A Phase 1 study testing VV119(SAD) and VV119(FE) in people with Schizophrenia, run by Vigonvita Life Sciences at 1 site in China.
Trial summary
This study will consist of 2 parts: Part Ⅰ - Single Ascending Dose (SAD) study, Part Ⅱ - Food Effect (FE) study Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- VV119(SAD) and VV119(FE)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2023to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males:aged 18 to 45 years old, males ,Body weight no less than 50.0 kg ; females :Aged 18 to 60 years old ,Body weight no less than 45.0 kg ,Body Mass Index of 19.0 to 26.0kg/m2,
- Medically healthy, Physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or abnormal without clinical significance,
- Males subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed; females not of child-bearing potential,
- Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.
Who cannot join
- Unless otherwise noted, the exclusion criteria were consistent for subjects in the SAD study and FE study. The following subjects will be excluded:
- With current or past medical history diseases or dysfunction that affect the clinical trial, evaluated by the investigator, including but not limited to central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood system, ophthalmology and other diseases, history of malignant tumor or other diseases that are not suitable for participating in the clinical trial;
- With current or previous mental disorders and brain dysfunction, or suicide risk according to the clinical judgment of the investigator, or a history of self-mutilation;
- With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, history of gastrointestinal bleeding, etc.
- With a known history of allergy to investigating drug ingredients or similar drugs, a history of allergic diseases or allergic constitution;
- Positive for hepatitis B virus surface antigen (HBsAg), or syphilis antibody (Anti-TP), or hepatitis C antibody (anti-HCV), or human immunodeficiency virus antigen/antibody combined detection (HIV-Ag/Ab);
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- With a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial;
- With a blood donation or blood loss ≥ 400 mL within 3 months before screening, or a blood donation or blood loss ≥ 200 mL within 1 month, or a history of blood product use within 3 months before screening;
- Taking any prescription drugs, over-the-counter drugs, and any functional vitamins or herbal products within 2 weeks before screening;
- Using any drugs that inhibit or induce hepatic drug metabolizing enzymes CYP3A4, CYP3A5, CYP2D6 (such as inducers - phenobarbital, rifampicin, carbamazepine, phenytoin sodium, glucocorticoids, etc.; inhibitors - ketoconazole, itraconazole, cimetidine, clarithromycin, verapamil, erythromycin, etc.) within 4 weeks (or 5 half-lives, whichever is longer) before screening;
- Participating in any clinical trial and taking clinical trial drugs within 3 months before screening, or being participating in other clinical trials;
- Smoke test positive or smoking more than 5 cigarettes per day or average intake of coffee or tea more than 5 cups per day (200 mL/cup) within 3 months before screening, or unable to stop users during the study;
- With alcohol abuse within 1 year before screening, average weekly alcohol intake more than 14 standard units [1 unit = 360 mL beer (alcohol content 5%) or 45 mL spirits (alcohol content 40%) or 150 mL wine (alcohol content 12%)] or positive for alcohol breath test;
- With a history of drug abuse within 1 year before screening, or positive for urine drug screening;
- With a family history of sudden cardiac death (sudden death age less than 40 years);
- With a resting pulse < 50 beats/min or ≥ 100 beats/min; resting systolic blood pressure < 85 mmHg or ≥ 140 mmHg; resting diastolic blood pressure < 50 mmHg or ≥ 90 mmHg; systolic blood pressure decreased by ≥ 20 mmHg and/or diastolic blood pressure decreased by ≥ 10 mmHg and/or accompanied by clinical symptoms within 3 minutes of standing;
- Abnormal in 12-lead electrocardiogram (ECG), clinically significant judged by the investigator (e.g., QTcF> 450 ms in men and > 470 ms in women);
- With the aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (Cr), urea (Urea), serum prolactin levels beyond the upper limit of normal (ULN);
- Having special requirements for food, unable to observe a unified diet or having dysphagia;
- Rejecting abide by the following conditions during the trial: smoking, alcohol or caffeine-containing beverages are prohibited, and strenuous exercise is avoided;
- Directly related to this clinical trial;
- Other subjects that the investigator considers inappropriate for this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality, 100088
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Food Effects of a Single Oral VV119 Capsule in Healthy Chinese Volunteers
This study will consist of 2 parts: Part Ⅰ - Single Ascending Dose (SAD) study, Part Ⅱ - Food Effect (FE) study
Read the detailed description
Part Ⅰ were designed as single-center, randomized, double-blind, placebo-controlled, dose-escalation trials to assess the safety, tolerability, pharmacokinetic (PK) of single oral doses of VV119 in healthy adult subjects.
Part Ⅱ is a single-center, randomized, open label, 2×2 crossover design to assess the high-fat meal effects on PK of a single oral dose of VV119 in healthy adult subjects.
- Conditions
- Schizophrenia
- Being tested
- VV119(SAD), VV119 Placebo(SAD), VV119(FE)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VV119(SAD)Drug
VV119 0.2 mg Group: 2 subjects will receive VV119 0.2 mg, orally; VV119 0.5 mg Group: 6 subjects will receive VV119 0.5 mg, orally; VV119 1 mg Group: 6 subjects will receive VV119 1 mg, orally; VV119 2 mg Group: 6 subjects will receive VV119 2 mg, orally; VV119 3 mg Group:6 subjects will receive VV119 3 mg, orally; VV119 4.5 mg Group:6 subjects will receive VV119 4.5 mg, orally; VV119 6 mg Group:6 subjects will receive VV119 6 mg, orally; VV119 8 mg Group:6 subjects will receive VV119 8 mg, orally; VV119 10 mg Group:6 subjects will receive VV119 10 mg, orally;
VV119 Placebo(SAD)Drug
VV119 0.5 mg Group: 2 subjects will receive VV119 Placebo 0.5 mg, orally; VV119 1 mg Group: 2 subjects will receive VV119 Placebo 1 mg, orally; VV119 2 mg Group: 2 subjects will receive VV119 Placebo 2 mg, orally; VV119 3 mg Group:2 subjects will receive VV119 Placebo 3 mg, orally; VV119 4.5 mg Group:2 subjects will receive VV119 Placebo 4.5 mg, orally; VV119 6 mg Group:2 subjects will receive VV119 Placebo 6 mg, orally; VV119 8 mg Group:2 subjects will receive VV119 Placebo 8 mg, orally; VV119 10 mg Group:2 subjects will receive VV119 Placebo 10 mg, orally;
VV119(FE)Drug
A：2 mg VV119, following an overnight fast of at least 10 hours for Period 1; 2mg VV119, administered 30 minutes after the start of a high-fat meal for Period 2; B: 2mg VV119, administered 30 minutes after the start of a high-fat meal for Period 1;2mg VV119, following an overnight fast of at least 10 hours for Period 2；
| Study group | Role | What they receive |
|---|---|---|
| Part Ⅰ - Single Ascending Dose (SAD) study: Experimental | Experimental | Subjects will receive VV119 orally for single dose. Receives: Drug: VV119(SAD) |
| Part Ⅰ - Single Ascending Dose (SAD) study: Placebo | Experimental | Subjects will receive VV119 placebo orally for single dose. Receives: Drug: VV119 Placebo(SAD) |
| Part Ⅱ - Food Effect (FE) study: Experimental | Experimental | Subjects will receive VV119 orally for single dose. Receives: Drug: VV119(FE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Measured: 23 days after treatment in part Ⅰ;
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Measured: 56 days after treatment in part Ⅱ;
Cmax
maximum observed plasma concentration of VV119 and the main metabolites
Measured: 360 hours after dosing in part Ⅰ;
Cmax
maximum observed plasma concentration of the main metabolites VV119-M2
Measured: 480 hours after dosing in part Ⅱ;
area under the plasma concentration time curve from time zero to the last(AUC0-t)
area under the plasma concentration time curve from time zero to the last of VV119 and the main metabolites
Measured: 360 hours after dosing in part Ⅰ;
area under the plasma concentration time curve from time zero to the last(AUC0-t)
area under the plasma concentration time curve from time zero to the last of the main metabolites VV119-M2
Measured: 480 hours after dosing in part Ⅱ;
AUC0-∞
area under the plasma concentration time curve from time zero to infinity of VV119 and the main metabolites
Measured: 360 hours after dosing in part Ⅰ;
AUC0-∞
area under the plasma concentration time curve from time zero to infinity of the main metabolites VV119-M2
Measured: 480 hours after dosing in part Ⅱ;
Tmax
time at which Cmax occurs of VV119 and the main metabolites of VV119 and the main metabolites
Measured: 360 hours after dosing in part Ⅰ;
Tmax
time at which Cmax occurs of VV119 and the main metabolites of the main metabolites VV119-M2
Measured: 480 hours after dosing in part Ⅱ;
t1/2
half life of elimination of VV119 and the main metabolites
Measured: 360 hours after dosing in part Ⅰ;
t1/2
half life of elimination of the main metabolites VV119-M2
Measured: 480 hours after dosing in part Ⅱ;
Apparent Clearance Rate（CL/F）
apparent clearance of VV119 and the main metabolites
Measured: 360 hours after dosing in part Ⅰ;
Apparent Clearance Rate（CL/F）
apparent clearance of the main metabolites VV119-M2
Measured: 480 hours after dosing in part Ⅱ;
Vd/F
apparent volume of distribution during the terminal phase of VV119 and the main metabolites
Measured: 360 hours after dosing in part Ⅰ;
Vd/F
apparent volume of distribution during the terminal phase of the main metabolites VV119-M2
Measured: 480 hours after dosing in part Ⅱ;
Ke
elimination rate constant of VV119 and the main metabolites
Measured: 360 hours after dosing in part Ⅰ;
Ke
elimination rate constant of the main metabolites VV119-M2
Measured: 480 hours after dosing in part Ⅱ;
mean Resident Time from time zero to the last（MRT0-t）
mean Resident Time from time zero to the last of VV119 of VV119 and the main metabolites
Measured: 360 hours after dosing in part Ⅰ;
mean Resident Time from time zero to the last（MRT0-t）
mean Resident Time from time zero to the last of the main metabolites VV119-M2
Measured: 480 hours after dosing in part Ⅱ;
mean Resident Time from time zero to infinity（MRT0-∞)
mean Resident Time from time zero to infinity of VV119 and the main metabolites
Measured: 360 hours after dosing in part Ⅰ;
mean Resident Time from time zero to infinity（MRT0-∞)
mean Resident Time from time zero to infinity of the main metabolites VV119-M2
Measured: 480 hours after dosing in part Ⅱ;
AUC_%Extra
area under plasma Concentration (AUC) extrapolated of VV119 and the main metabolites
Measured: 360 hours after dosing in part Ⅰ;
AUC_%Extra
area under plasma Concentration (AUC) extrapolated of the main metabolites VV119-M2
Measured: 480 hours after dosing in part Ⅱ;
BP
Blood Plasma Ratio of the main metabolites VV119-M2
Measured: 360 hours after dosing in part Ⅰ;
BP
Blood Plasma Ratio of VV119 and the main metabolites
Measured: 480 hours after dosing in part Ⅱ;
Secondary outcomes (1)
Metabolite Identification
Identification of the structure of the main metabolites of VV119 in plasma,Urine and feces
Measured: 360 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start27 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Vigonvita Life SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gang Wang, Principal investigator, Beijing Anding Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105151
- Sponsor's protocol ID
- VV119-01
- Status last verified
- Aug 2026
- First submitted
- 17 Oct 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Food Effects of a Single Oral VV119 Capsule in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT06105151
- Acronym / sponsor ID
- VV119-01
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will consist of 2 parts: Part Ⅰ - Single Ascending Dose (SAD) study, Part Ⅱ - Food Effect (FE) study
Detailed description
Part Ⅰ were designed as single-center, randomized, double-blind, placebo-controlled, dose-escalation trials to assess the safety, tolerability, pharmacokinetic (PK) of single oral doses of VV119 in healthy adult subjects.
Part Ⅱ is a single-center, randomized, open label, 2×2 crossover design to assess the high-fat meal effects on PK of a single oral dose of VV119 in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part Ⅰ - Single Ascending Dose (SAD) study: Experimental | Experimental | Drug: VV119(SAD)Subjects will receive VV119 orally for single dose. |
| Part Ⅰ - Single Ascending Dose (SAD) study: Placebo | Experimental | Drug: VV119 Placebo(SAD)Subjects will receive VV119 placebo orally for single dose. |
| Part Ⅱ - Food Effect (FE) study: Experimental | Experimental | Drug: VV119(FE)Subjects will receive VV119 orally for single dose. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males:aged 18 to 45 years old, males ,Body weight no less than 50.0 kg ; females :Aged 18 to 60 years old ,Body weight no less than 45.0 kg ,Body Mass Index of 19.0 to 26.0kg/m2,
- Medically healthy, Physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or abnormal without clinical significance,
- Males subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed; females not of child-bearing potential,
- Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.
Key exclusion criteria (22 listed)
- Unless otherwise noted, the exclusion criteria were consistent for subjects in the SAD study and FE study. The following subjects will be excluded:
- With current or past medical history diseases or dysfunction that affect the clinical trial, evaluated by the investigator, including but not limited to central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood system, ophthalmology and other diseases, history of malignant tumor or other diseases that are not suitable for participating in the clinical trial;
- With current or previous mental disorders and brain dysfunction, or suicide risk according to the clinical judgment of the investigator, or a history of self-mutilation;
- With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, history of gastrointestinal bleeding, etc.
- With a known history of allergy to investigating drug ingredients or similar drugs, a history of allergic diseases or allergic constitution;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VV119(SAD)VV119 0.2 mg Group: 2 subjects will receive VV119 0.2 mg, orally; VV119 0.5 mg Group: 6 subjects will receive VV119 0.5 mg, orally; VV119 1 mg Group: 6 subjects will receive VV119 1 mg, orally; VV119 2 mg Group: 6 subjects will receive VV119 2 mg, orally; VV119 3 mg Group:6 subjects will receive VV119 3 mg, orally; VV119 4.5 mg Group:6 subjects will receive VV119 4.5 mg, orally; VV119 6 mg Group:6 subjects will receive VV119 6 mg, orally; VV119 8 mg Group:6 subjects will receive VV119 8 mg, orally; VV119 10 mg Group:6 subjects will receive VV119 10 mg, orally; | Drug | Part Ⅰ - Single Ascending Dose (SAD) study: Experimental |
| VV119 Placebo(SAD)VV119 0.5 mg Group: 2 subjects will receive VV119 Placebo 0.5 mg, orally; VV119 1 mg Group: 2 subjects will receive VV119 Placebo 1 mg, orally; VV119 2 mg Group: 2 subjects will receive VV119 Placebo 2 mg, orally; VV119 3 mg Group:2 subjects will receive VV119 Placebo 3 mg, orally; VV119 4.5 mg Group:2 subjects will receive VV119 Placebo 4.5 mg, orally; VV119 6 mg Group:2 subjects will receive VV119 Placebo 6 mg, orally; VV119 8 mg Group:2 subjects will receive VV119 Placebo 8 mg, orally; VV119 10 mg Group:2 subjects will receive VV119 Placebo 10 mg, orally; | Drug | Part Ⅰ - Single Ascending Dose (SAD) study: Placebo |
| VV119(FE)A：2 mg VV119, following an overnight fast of at least 10 hours for Period 1; 2mg VV119, administered 30 minutes after the start of a high-fat meal for Period 2; B: 2mg VV119, administered 30 minutes after the start of a high-fat meal for Period 1;2mg VV119, following an overnight fast of at least 10 hours for Period 2； | Drug | Part Ⅱ - Food Effect (FE) study: Experimental |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 23 days after treatment in part Ⅰ;
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Time frame: 56 days after treatment in part Ⅱ;
Incidence of Treatment-Emergent Adverse Events
Cmax
Time frame: 360 hours after dosing in part Ⅰ;
maximum observed plasma concentration of VV119 and the main metabolites
Cmax
Time frame: 480 hours after dosing in part Ⅱ;
maximum observed plasma concentration of the main metabolites VV119-M2
area under the plasma concentration time curve from time zero to the last(AUC0-t)
Time frame: 360 hours after dosing in part Ⅰ;
area under the plasma concentration time curve from time zero to the last of VV119 and the main metabolites
area under the plasma concentration time curve from time zero to the last(AUC0-t)
Time frame: 480 hours after dosing in part Ⅱ;
area under the plasma concentration time curve from time zero to the last of the main metabolites VV119-M2
AUC0-∞
Time frame: 360 hours after dosing in part Ⅰ;
area under the plasma concentration time curve from time zero to infinity of VV119 and the main metabolites
AUC0-∞
Time frame: 480 hours after dosing in part Ⅱ;
area under the plasma concentration time curve from time zero to infinity of the main metabolites VV119-M2
Tmax
Time frame: 360 hours after dosing in part Ⅰ;
time at which Cmax occurs of VV119 and the main metabolites of VV119 and the main metabolites
Tmax
Time frame: 480 hours after dosing in part Ⅱ;
time at which Cmax occurs of VV119 and the main metabolites of the main metabolites VV119-M2
t1/2
Time frame: 360 hours after dosing in part Ⅰ;
half life of elimination of VV119 and the main metabolites
t1/2
Time frame: 480 hours after dosing in part Ⅱ;
half life of elimination of the main metabolites VV119-M2
Apparent Clearance Rate（CL/F）
Time frame: 360 hours after dosing in part Ⅰ;
apparent clearance of VV119 and the main metabolites
Apparent Clearance Rate（CL/F）
Time frame: 480 hours after dosing in part Ⅱ;
apparent clearance of the main metabolites VV119-M2
Vd/F
Time frame: 360 hours after dosing in part Ⅰ;
apparent volume of distribution during the terminal phase of VV119 and the main metabolites
Vd/F
Time frame: 480 hours after dosing in part Ⅱ;
apparent volume of distribution during the terminal phase of the main metabolites VV119-M2
Ke
Time frame: 360 hours after dosing in part Ⅰ;
elimination rate constant of VV119 and the main metabolites
Ke
Time frame: 480 hours after dosing in part Ⅱ;
elimination rate constant of the main metabolites VV119-M2
mean Resident Time from time zero to the last（MRT0-t）
Time frame: 360 hours after dosing in part Ⅰ;
mean Resident Time from time zero to the last of VV119 of VV119 and the main metabolites
mean Resident Time from time zero to the last（MRT0-t）
Time frame: 480 hours after dosing in part Ⅱ;
mean Resident Time from time zero to the last of the main metabolites VV119-M2
mean Resident Time from time zero to infinity（MRT0-∞)
Time frame: 360 hours after dosing in part Ⅰ;
mean Resident Time from time zero to infinity of VV119 and the main metabolites
mean Resident Time from time zero to infinity（MRT0-∞)
Time frame: 480 hours after dosing in part Ⅱ;
mean Resident Time from time zero to infinity of the main metabolites VV119-M2
AUC_%Extra
Time frame: 360 hours after dosing in part Ⅰ;
area under plasma Concentration (AUC) extrapolated of VV119 and the main metabolites
AUC_%Extra
Time frame: 480 hours after dosing in part Ⅱ;
area under plasma Concentration (AUC) extrapolated of the main metabolites VV119-M2
BP
Time frame: 360 hours after dosing in part Ⅰ;
Blood Plasma Ratio of the main metabolites VV119-M2
BP
Time frame: 480 hours after dosing in part Ⅱ;
Blood Plasma Ratio of VV119 and the main metabolites
1 secondary outcome
Metabolite Identification
Time frame: 360 hours after dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Wang principal investigator
Beijing Anding Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VV119(SAD) and VV119(FE) in people with Schizophrenia, run by Vigonvita Life Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 23 days after treatment in part Ⅰ;). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.